Ropinerole

Brand Egis

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Clinical Pharmacology

Anti-Parkinsonian Dopamine Agonist

Indications

Parkinson's disease:

- monotherapy of early stages of the disease in patients who need dopaminergic therapy in order to delay the prescription of levodopa drugs.

- as a combination therapy in patients receiving levodopa preparations in order to increase the effectiveness of levodopa, including controlling fluctuations of the therapeutic effect of levodopa (on-off phenomenon) and the “end of dose” effect against the background of chronic levodopa therapy doses of levodopa.

Composition

On 1 tablet:

Active ingredient: ropinirole hydrochloride 2.28 mg, which corresponds to ropinirole 2 mg.

Excipients: methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [2: 0.1: 1] 5.28 mg; hypromellose 89,955 mg; sodium lauryl sulfate 6.75 mg; copovidone 44.64 mg; magnesium stearate 1.095 mg.

Casing: opadry II pink 32К14834 (4.5 mg) / opadry yellowish brown OY-27207 (9 mg) / opadry red 03В25227 (18 mg).

Opadry II pink 32K14834: lactose monohydrate 40% (1.8 mg); hypromellose 2910 (hypromellose 15cP) 28% (1.26 mg); titanium dioxide 23.46% (1.0557 mg); Triacetin 8% (0.36 mg); iron dye red oxide 0.54% (0.0243 mg).

Opadry yellowish brown OY-27207: hypromellose-2910 (hypromellose-6cP) 62.5% (5.625 mg); titanium dioxide 21.25% (1.9125 mg); dye sundown yellow, aluminum varnish (FD & Yellow # 6) (E110) 9% (0.81 mg); macrogol-400 6.25% (0.5625 mg); indigo carmine, aluminum varnish (FD & C blue # 2) (E132) 1% (0.09 mg).

Opadry red 03B25227: hypromellose-2910 (hypromellose-BCP) 62.5% (11.25 mg); titanium dioxide 24.19% (4.3542 mg); macrogol-400 6.25% (1.125 mg); iron dye red oxide 6.14% (1.105 mg); iron dye black oxide 0.89% (0.1602 mg); iron dye yellow oxide 0.03% (0.0054 mg).

Ropinerole is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Sindranol	Egis	Hungary	pills
Requip modutab	GlaxoSmithKline	UK	pills

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Dosage and Administration

Take inside. Sindranol® should be taken once a day at the same time, regardless of the meal. Patients to achieve the required dose of ropinirole is recommended to take the minimum number of pills with prolonged action, using the maximum possible dosage of pills of the drug. In some patients, simultaneous use with fatty foods may increase AUC and / or C max in 2 times.

Sindranol® pills should be swallowed whole. Do not chew or divide into pieces, since the shell of the tablet provides a prolonged release of ropinirole.

It is recommended that individual selection of the dose of the drug, taking into account the effectiveness and tolerability. If the patient is drowsy at any stage of dose selection, it is recommended to reduce the dose of the drug. With the development of other adverse reactions it is necessary to reduce the dose of the drug, followed by a gradual increase in the dose.

The need for dose selection should be considered when skipping a dose (one or more).

Monotherapy

Initial dose selection

The recommended starting dose of Sindranol® is 2 mg once a day for the first week. In the second week, the dose should be increased to 4 mg once a day. The therapeutic effect can be achieved with the use of the drug Sindranol® at a dose of 4 mg once a day.

Treatment regimen

It is necessary to carry out therapy ropinirole in the minimum effective dose. In the future, if necessary, increase the dose by 2 mg at intervals of at least 1 week to 8 mg per day.

If the therapeutic effect of Sindranol® at a dose of 8 mg / day is not sufficiently pronounced or is unstable, you can continue to increase the daily dose of the drug by 2-4 mg every 2 weeks or at longer intervals (until the desired therapeutic effect is achieved). The maximum daily dose is 24 mg in a single dose.

Combination therapy

With simultaneous use of the drug Sindranol® in doses used in monotherapy with levodopa, a gradual reduction in the dose of levodopa (up to 30%) is possible, depending on the clinical effect. In patients with progressive form of Parkinson's disease who are simultaneously receiving levodopa, dyskinesia may develop during the selection of a dose of ropinirole prolonged release. If dyskinesia occurs, the dose of levodopa should be reduced.

In the case of switching from therapy with another dopamine receptor agonist to the drug Sindranol®, it is necessary to follow the recommendations regarding the withdrawal of the previously taken drug.

Cancel therapy

As in the case of other dopamine receptor agonists, Sindranol® should be abolished gradually, reducing the daily dose for at least 1 week.

Interruption of therapy

When skipping a dose (one or more) and further resuming therapy, it is necessary to repeat the selection of the dose.

Special patient groups

Elderly patients

After oral ingestion, ropinirole clearance is reduced by approximately 15% in elderly patients compared with younger patients. Dose adjustment in this category of patients is not required.

In patients aged 75 years and older, a slower dose selection is advisable.

Renal dysfunction

In patients with mild or moderate renal dysfunction (CC 30-50 ml / min), the clearance of ropinirole does not change. Therefore, dose adjustment of ropinirole is not required. The recommended starting dose of ropinirole in patients with end-stage renal failure on hemodialysis is 2 mg once a day. In the future, the dose is increased, taking into account the tolerability and effectiveness of the drug. The maximum daily dose of ropinirole in patients on programmed (chronic) hemodialysis is 18 mg. Taking additional doses after hemodialysis is not required.

In patients with severe renal insufficiency (CC <30 ml="" min="" who="" are="" not="" receiving="" treatment="" with="" programmed="" chronic="" hemodialysis="" the="" use="" of="" ropinirole="" has="" been="" studied="" p="">

Adverse reactions

The adverse reactions listed below are listed in accordance with the damage of organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often: ≥1 / 10; often: ≥1 / 100 to <1/10; infrequently: from ≥1 / 1000 to <1/100; rarely: from ≥1 / 10,000 to <1/1000; very rarely: <1/10 000; frequency unknown: cannot be estimated based on available data.

Within each group, the frequency of adverse reactions is presented in order of decreasing significance.

Contraindications

- Hypersensitivity to ropinirole or any of the components that make up the drug;

- severe renal failure (creatinine clearance (CC) <30 ml="" min="" in="" patients="" not="" receiving="" programmed="" chronic="" hemodialysis="" treatment="" p="">

- abnormal liver function;

- age up to 18 years;

- breastfeeding period;

- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.

Carefully:

With caution, ropinirole is prescribed to patients with severe diseases of the cardiovascular system and with severe cardiovascular insufficiency.

Ropinirol can be prescribed to patients with a history of psychotic disorders only in cases where the expected benefit from its use outweighs the potential risk.

Drug interactions

There was no marked pharmacokinetic interaction between ropinirole and levodopa or domperidone, which would require dose adjustment of these drugs.

Neuroleptics and other centrally acting dopamine receptor antagonists, such as sulpiride or metoclopramide, can reduce the effectiveness of ropinirole, so the simultaneous use of these drugs should be avoided.

In patients who received high doses of estrogen, there was an increase in plasma plasma ropinirole. In women who have already received hormone replacement therapy (HRT) before the start of treatment with ropinirole, dose adjustment of ropinirole is not required. However, in the case of the appointment of HRT or its cancellation during treatment with ropinirole, a dose adjustment of the drug Sindranol® may be required.

Ropinirole is mainly metabolized by the CYP1A2 isoenzyme. With simultaneous use of ropinirole (at a dose of 2 mg three times a day) with ciprofloxacin, Cmax and AUC of ropinirole increased by 60% and 84%, respectively, which can lead to the development of adverse events. In this regard, in patients receiving ropinirol, its dose should be adjusted when prescribing or withdrawing drugs that inhibit CYP1A2 isoenzyme, such as ciprofloxacin, enoxacin or fluvoxamine.

In patients with Parkinson's disease who took both digoxin, there was no interaction between digoxin and ropinirole, which would require dose adjustment. The pharmacokinetic interaction between ropinirole (at a dose of 2 mg three times a day) and theophylline, a substrate of the CYP1A2 isoenzyme, was not observed in patients with Parkinson's disease.

Information about the possibility of the interaction of ropinirole and alcohol is not. As with other centrally acting drugs, patients should be warned about the need to refrain from taking alcohol during treatment with ropinirole.

Nicotine increases the activity of the CYP1A2 isoenzyme. If the patient stops or begins to smoke during treatment with ripinirol, a dose adjustment may be necessary.

Pregnancy and Lactation

Not enough data on the use of ropinirole in pregnant women. Animal studies have revealed reproductive toxicity. The potential risk of use in pregnant women is unknown, so the use of the drug during pregnancy is possible if the potential benefit to the mother exceeds the risk to the fetus.

It should not be used during breastfeeding, as it can inhibit lactation.

Special instructions

Considering the risk of arterial hypotension in patients with severe cardiovascular insufficiency (in particular, with coronary heart disease), it is recommended to monitor blood pressure, especially at the beginning of treatment. Simultaneous use with antihypertensives and antiarrhythmic drugs has not been studied. Caution should be exercised with the simultaneous use of these drugs, as the risk of hypotension, bradycardia or other arrhythmias is unknown.

Patients with psychotic disorders or with a history of them should be prescribed dopamine receptor agonists only in cases where the expected benefit of the use outweighs the potential risk.

Patients should be warned about the possible development of drowsiness or episodes of sudden sleep, sometimes without prior sleepiness. In the event of such reactions, consideration should be given to discontinuing ropinirole therapy.

Impaired control impulses (disorders of habits and cravings)

It is necessary to regularly monitor the possibility of the development of impulse control disorders. Patients and their caregivers should be informed that the use of dopamine receptor agonists, including ropinirole, may develop impulse drive syndrome, including compulsive behavior, including a craving for gambling, increased libido, hypersexuality, irresistible craving for purchases , binge eating. Disorders of desire, as a rule, are reversible after dose reduction or drug withdrawal.

In some cases, when ropinirole is used, other risk factors may include a history of compulsive behavior or the combined use of several dopaminergic drugs. In this case, consider the possibility of reducing the dose or cancellation of therapy.

Paradoxical deterioration in restless legs syndrome was noted with ropinirole therapy (earlier onset, increased intensity of manifestations, or progression of symptoms with the capture of previously unaffected extremities), or rebound syndrome (recurrence of symptoms) in the early morning hours (recurrence of symptoms in the early morning hours) . With the appearance of these symptoms, it is necessary to revise the tactics of treatment with ropinirole, to clarify the dosage up to the possible withdrawal of the drug.

The drug Sindranol® is produced in the form of pills of prolonged action, film-coated, with the property of release of the active substance within 24 hours. In the case of rapid passage of the drug through the gastrointestinal tract, there is a risk of incomplete release of the drug substance and transfer of its residue to the stool.

Special information on excipients

The drug contains lactose, therefore, is contraindicated in patients with lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.

Impact on the ability to drive trans. Wed and fur .:

Patients should be warned of possible adverse reactions during ropinirole therapy. Patients should be informed that there are very rare cases of the development of episodes of sudden falling asleep without any precursors and cases of dizziness (up to vertigo).

If a patient develops drowsiness during the day and / or there are episodes of sudden falling asleep during the day, requiring active intervention, the patient should be warned that he should not drive a car, and he should avoid other activities that require high-speed psychomotor reactions.